Clinical Research Evaluating Smoking Cessation With E-Cigarettes and Nicotine Therapy

NCT06948058 | Recruiting

• 2 other identifiers: STUDY00000326P20GM130414
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This project will investigate the effects of alternative nicotine products on smoking, weight gain, and related outcomes.

Conditions

Smoking Cessation; Obesity and Obesity-related Medical Conditions

Keywords

obesity; electronic cigarettes; harm reduction

Outcome Measures

Primary Outcomes (3)

• number of cigarettes per day

  Daily use of cigarettes will be determined using the Timeline Follow-Back (TLFB) in follow-up assessments.

  2 months

• carbon monoxide (CO)

  Exhaled breath sample used to measure carbon monoxide

  2 months

• number of quit attempts

  Number of attempts to quit smoking during the experimental period

  2 months

Secondary Outcomes (9)

• product acceptability

  2 months

• product adherence

  2 months

• change in weight

  2 months

• change in waist circumference

  2 months

• A1c

  2 months

Study Arms (3)

Electronic Cigarette (EC) Condition

EXPERIMENTAL

Participants in this condition will receive the EC intervention.

Other: Electronic Cigarettes (EC)

Nicotine Replacement Therapy Condition

EXPERIMENTAL

Participants in this condition will receive the NRT intervention.

Other: Nicotine replacement therapy (NRT)

No-Product Control Condition (CON)

NO INTERVENTION

Participants in this condition will not receive any alternate nicotine product.

Interventions

Electronic Cigarettes (EC) OTHER

Participants will receive information about the comparative risk of alternative nicotine products relative to smoking and will be asked to switch to EC for 8 weeks, with EC provided.

Electronic Cigarette (EC) Condition

Nicotine replacement therapy (NRT) OTHER

Participants will receive information about the comparative risk of alternative nicotine products relative to smoking and will be asked to switch to combination NRT (transdermal + oral) for 8 weeks, with NRT provided.

Nicotine Replacement Therapy Condition

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• body mass index (BMI) ≥ 30 kg/m2 (i.e., obese)
• smoked ≥ 5 cigarettes/day during the past year
• or older (due to minimum legal age EC restrictions)
• exhaled breath carbon monoxide (CO) level \> 6 ppm at Baseline (BL) (to confirm self-reported smoking)
• willing to use EC or NRT for 8 weeks
• access to a Bluetooth-enabled smartphone/tablet (to permit remote measurement of CO and other outcome variables)

You may not qualify if:

• received smoking cessation treatment of any kind in the past 30 days (actively quitting smoking),
• currently using EC or NRT more than 2 days/week (this may affect responses to study-supplied products)
• hospitalized for mental illness in past 30 days
• heart-related event (e.g., heart attack, severe angina) in past 30 days
• residing with another person currently enrolled in the study
• pregnant, nursing, or planning to become pregnant in the next 6 months
• medical contraindication for study or product use (e.g., allergy to adhesives)
• taken prescription weight loss medication in the last 30 days

Sponsors & Collaborators

• Brown University: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Brown University

Providence, Rhode Island, 02912, United States

RECRUITING

MeSH Terms

Conditions

Smoking Cessation; Obesity; Vaping; Harm Reduction

Interventions

Electronic Nicotine Delivery Systems; Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Smoking

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture; Drug Therapy; Therapeutics

Central Study Contacts

CRESCENT Study Research Staff

CONTACT

401-203-5339; CRESCENT@brown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor will not know the outcome of randomized assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A 3-group design.

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 29, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Clinical Laboratory Core data collected to fulfill the aims of the Center for Addiction and Disease Risk Exacerbation will be available to request immediately following publication, with no prespecified end date.
• Access Criteria: After all data are collected and the results of the study are published, deidentified data and biospecimens may be made available to other qualified investigators at Brown or other institutions upon request. The request will be evaluated by the investigators to ensure that it meets reasonable demands of scientific integrity.

Locations

US (1)